Cognitive Behavioral Therapy for Paternal Perinatal Depression / Fathers / Perinatal Depression · Interventional Study

Group CBT for Paternal Perinatal Depression RCT

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry entry for a planned but not-yet-recruiting RCT of online group cognitive behavioural therapy versus usual care for paternal perinatal depression in Ontario, Canada. No results are available; the record documents the intended study design and primary outcome measure only.

What was studied

Interventional, Randomized, Parallel, Double masking, Treatment purpose. Perinatal Depression, Fathers; Male; age from 18 Years. Intervention: 9-Week Group Cognitive Behavioural Therapy Intervention. Compared with: Control/Usual Care — No Intervention. n = 112. 1 site: Canada.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a trial registration for a planned RCT with no results yet reported; the study has not yet begun recruitment and provides only design and protocol information.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS) (assessed at 9 weeks)

DesignInterventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationPerinatal Depression, Fathers; Male; age from 18 Years

Sample size112

Intervention9-Week Group Cognitive Behavioural Therapy Intervention

ComparatorControl/Usual Care — No Intervention

Setting1 site: Canada

Reported figures

Quoted from the source exactly as published.

Planned sample size112

Primary outcome measureEdinburgh Postnatal Depression Scale (EPDS)

Primary outcome timepoint9 weeks

Caveats

This is a registry entry only; no trial results have been reported.
Recruitment has not yet begun (status: NOT_YET_RECRUITING).
Blinding, allocation concealment, sample size justification, and secondary outcomes are not described in this registry record.
Eligibility criteria beyond geography and symptom timing are not specified in the source text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized controlled trial design stated; allocation 1:1 to intervention or control.

Directness

strong

Primary outcome is paternal depression symptoms measured by EPDS at 9 weeks.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

insufficient

Blinding, allocation concealment, and other bias mitigation details not stated in registry.

Sample adequacy

limited

Planned enrollment 112 participants; adequacy depends on unreported power calculation.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07758036). This is a study registration, not published results. Lead sponsor: McMaster University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 112 participants (ESTIMATED). Conditions: Perinatal Depression, Fathers. Interventions: BEHAVIORAL: Cognitive Behavioral Therapy for Paternal Perinatal Depression. Primary outcome measures: Paternal Perinatal Depression Symptoms - Edinburgh Postnatal Depression Scale (EPDS) , 9 weeks. Brief summary: The purpose of the proposed study is to determine the effectiveness of an online, 9-week group CBT intervention for paternal perinatal depression in fathers and fathers-to-be. Fathers or fathers-to-be living in Ontario, Canada who have depression symptoms while their partner has been pregnant and/or during the first 18 months of their child's life will be assigned with a 50/50 chance (like flipping a coin) to receive online group CBT in addition to usual care, or to receive usual care only.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Cognitive Behavioral Therapy for Paternal Perinatal DepressionFathersPerinatal DepressionNCT07758036McMaster University